Edwards Lifesciences Corporation (EW) Friday announced that the U.S Food and Drug Administration, or the FDA, has granted conditional Investigational Device Exemption, or IDE, approval to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve.
Edwards Lifesciences stated that the single arm study will follow standard heart valve guidance and use historical controls. Heart valve trials typically enroll between 500-700 patients. The GLX technology will initially be studied on the company's market-leading Carpentier-Edwards PERIMOUNT Magna Ease Aortic Valve, and the study may be broadened to include other devices. The primary endpoints of the trial will measure valve safety and effectiveness.
The company further stated that the GLX technology is a proprietary tissue treatment allowing for packaging and sterilization in a dry condition, eliminating the need to rinse the valve before implantation.
"We are excited about beginning the clinical study of this unique tissue treatment platform in the U.S. with our Magna Ease valve," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "We hope that this study will be the first step towards establishing a new category of high performance heart valves treated with our GLX platform, and laying a foundation for our next generation valve technologies."
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